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The FDA said nothing about the payments from the North Chicago company when the panel met to assess new technology, a "breakthrough device" for which the agency "may be willing to accept greater uncertainty" when considering risks and benefits.
Most of the doctors the FDA tapped to advise it on an Abbott medical device previously had financial relationships with the company, a federal database shows. The FDA didn’t disclose the payments.
Some familiar with the process said the payments should have been disclosed in the interest of transparency.
The EPA is tightening regulation of ethylene oxide, a carcinogenic gas used to sterilize medical devices. The agency is trying to balance the interests of the health care industry supply chain with those of communities where the gas creates airborne health risks.
The Environmental Protection Agency is tightening regulation of ethylene oxide, a carcinogenic gas used to sterilize medical devices. The agency is trying to balance the interests of the health care industry supply chain with those of communities where the gas creates airborne health risks.